MAUDE Adverse Event Report: PENUMBRA, INC. NEURON MAX 6F 088 LONG SHEATH; DQY

Catalog Number	PNML6F088804
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Death (1802)
Date of Event	02/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Death is a potential adverse event with use of the neuron max and is included in the device labeling.Therefore, it was determined that the reported patient death was an anticipated procedural complication.The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.The hospital disposed of the device.
Event or Problem Description
The patient underwent a coil embolization procedure in the anterior communicating artery (aca) using a neuron max 6f 088 long sheath (neuron max) on (b)(6) 2018.During the procedure, the physician advanced the neuron max over a non-penumbra diagnostic catheter, and then exchanged the diagnostic catheter for a benchmark delivery catheter (benchmark) because the physician needed to advance past a 360 degree loop in the patient¿s anatomy and needed more distal access to reach the aneurysm.The physician then advanced a balloon catheter and a non-penumbra microcatheter through the benchmark and past the neck of the aneurysm into the left a2.The physician successfully placed five coils and two penumbra smart coils.An angiogram performed post-procedure revealed nothing out of the ordinary.A computed tomography (ct) was performed approximately 2 hours after the coil embolization had been completed, and during the ct, the patient suddenly became hemiplegic and developed aphasia.The patient, therefore, was returned to the angio suite, and the angiogram revealed a radio-opaque ring in the distal left m1 of the middle cerebral artery (mca).The physician attempted to remove the radio-opaque ring with multiple non-penumbra snare devices, however, was unsuccessful.The physician, therefore, administered heparin, plavin, and aspirin.The patient passed away on (b)(6) 2018 due to a massive brain edema.

• Brand Name: NEURON MAX 6F 088 LONG SHEATH
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7383361
• Report Number: 3005168196-2018-00630
• Device Sequence Number: 172893
• Product Code: DQY
• UDI-Device Identifier: 00814548012216
• UDI-Public: 00814548012216
• Combination Product (Y/N): N
• Initial Reporter Country: IR
• PMA/510(K) Number: K111380
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 07/26/2020
• Device Catalogue Number: PNML6F088804
• Device Lot Number: F78382
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2018
• Initial Report FDA Received Date: 03/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Life Threatening; Required Intervention
• Patient Age: 52 YR